Cardiac ArrestPhase 2ENDO-RCANCT02685618
Endothelial Dysfunction in Resuscitated Cardiac Arrest
A Phase 2 study testing Iloprost, Saline and Phillips M1006B, offset by -10mmHg in people with Cardiac Arrest, run by Pär Johansson at 1 site in Denmark.
Trial summary
Objective: Safety and efficacy of low-dose prostacyclin administration and blood pressure target in addition to standard therapy, as compared to standard therapy alone, in post-cardiac-arrest-syndrome (PCAS) patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Arrest
- What is being tested?
- Iloprost, Saline and Phillips M1006B, offset by -10mmHg
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteDenmark
- Study dates
- Feb 2016to 27 Feb 2017
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years
- OHCA of presumed cardiac cause
- Sustained ROSC*
- Unconsciousness (GCS <8) (patients not able to obey verbal commands) after sustained ROSC*
- Target temperature management is indicated.
Who cannot join
- Conscious patients (obeying verbal commands)
- Females of childbearing potential (unless a negative human chorionic gonadotropin (HCG) test can rule out pregnancy within the inclusion window)
- Patients weighing more than 135kg
- In-hospital cardiac arrest (IHCA)
- OHCA of presumed non-cardiac cause, e.g. after trauma or dissection/rupture of major artery OR Cardiac arrest caused by initial hypoxia (i.e. drowning, suffocation, hanging).
- Known congenital bleeding diathesis (medically induced coagulopathy due to treatment with Vitamin K antagonists, Thrombininhibitors, Factor Xa inihbitors, ADP-receptor inhibitors, Aspirin, Asasantin, Persantin, NSAID, unfractionated and low molecular weight heparin does NOT exclude the patient).
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- Suspected or confirmed acute intracranial bleeding
- Suspected or confirmed acute stroke
- Unwitnessed asystole
- Known limitations in therapy and Do Not Resuscitate-order
- Known disease making 180 days survival unlikely
- Known pre-arrest CPC 3 or 4
- >4 hours (240 minutes) from ROSC to screening
- Systolic blood pressure <80 mm Hg in spite of fluid loading/vasopressor and/or inotropic medication/intra-aortic balloon pump/axial flow device*
- Temperature on admission <30°C.
- Known allergy to Prostacyclin analogues
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safety and Efficacy of Low-dose Prostacyclin Administration and Blood Pressure Target in Addition to Standard Therapy, as Compared to Standard Therapy Alone, in Post-cardiac-arrest-syndrome Patients - a Randomized, Controlled, Double-blinded Investigator-initiated Trial.
Objective: Safety and efficacy of low-dose prostacyclin administration and blood pressure target in addition to standard therapy, as compared to standard therapy alone, in post-cardiac-arrest-syndrome (PCAS) patients.
Read the detailed description
Trial Rationale: Therapeutic interventions directed towards the damaged endothelium may improve outcome for patients with PCAS. Prostacyclin/Iloprost (PGI2) is an endogenous prostanoid which is formed and released by endothelial cells with anti-platelet, vasodilatory and cytoprotective properties36 and is expected to be beneficial by protecting and deactivating the endothelium and by restoring vascular integrity in patients suffering from endothelial breakdown.
Trial Population: Participants in the trial must be adult patients (≥18 years of age) with out-of-hospital cardiac arrest (OHCA) of presumed cardiac cause admitted to the Dept. of Cardiology, 2143, Rigshospitalet, Copenhagen.
Trial Design: Randomized, placebo controlled, double-blind investigator-initiated trial in 40 OHCA patients. 48 hours of active study drug (Iloprost, 1 ng/kg/min) versus placebo (saline) infusion.
Patients in both randomization groups will be treated in accordance with state-of-the art therapy including targeted temperature management. Interventions are considered emergency procedures and study drug infusion should be commenced as soon as possible after sustained return of spontaneous circulation (ROSC), screening and randomization.
Patients will only be enrolled after informed consent, but as the treatment has to be initiated earliest possible after the out of hospital cardiac arrest diagnosis i.e., at a time-point where patients are temporarily incompetent, scientific guardians will co-sign the informed consent form before inclusion. Next-of-kin and the patients' general practitioner will co-sign as soon as possible and the patient will provide informed consent whenever possible.
During the study, blood samples will be taken at different time points. Patients will be observed and assessed continuously with regards to complications including bleeding. Patients will be actively assessed as long as the patient is in the ICU. During the extended follow up period at day 30, 90 and 180 contact will be made with the patients to follow up on safety events and vital status.
The trial is conducted in accordance with the protocol and is approved by Danish health and medicines authority, Danish ethics committee and danish data protection agency.
Investigational product: The active treatment in the trial is 1 ng/kg/min Ilomedin® administered as a 48h continuous i.v infusion. The drugs will be administered according to the product specifications.
Placebo: The placebo is 0.9% saline administered as a 48h continuous i.v infusion. The i.v volume of placebo saline to be administered is equal to the administered volume of diluted (in 0.9% saline) active drug.
Sponsor of study and financial support: This research project is investigator-initiated by the trial Sponsor Pär I. Johansson in collaboration with the principal investigator Christian Hassager.
It has not received funding from any commercial sponsors.
Patient recruitment period runs from February 2016 to August 2016. Follow-up data on 30-day, 90-day and 180-day outcome and adverse events will be collected. Initial data analyses will be done after completion of 30-day follow-up for all patients. Secondary data analyses will be done after completion of 180-day follow-up for all patients.
- Conditions
- Cardiac Arrest
- Being tested
- Iloprost, Saline, Phillips M1006B, offset by -10mmHg, Philips M1006B, No offset
- Medical subject headings
- Heart Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IloprostDrug
Also called Ilomedin (R), Prostacyclin analogue (PGI2)
SalineDrug
Also called 0,9% NaCl
Phillips M1006B, offset by -10mmHgDevice
Administration of blood pressure module M1006B: offset by -10 mmHg
Philips M1006B, No offsetDevice
Administration of blood pressure module M1006B: No offset
| Study group | Role | What they receive |
|---|---|---|
| Iloprost + M1006B offset by -10 mmHg | Experimental | Administration of 1 ng/kg/min Ilomedin® as a 48h continuous i.v infusion. Administration of blood pressure modules M1006B: offset by -10 mmHg
Intervention: Drug: Iloprost + M1006B offset -10mmHg Receives: Drug: Iloprost; Device: Phillips M1006B, offset by -10mmHg |
| Iloprost + M1006B, No offset | Experimental | Administration of 1 ng/kg/min Ilomedin® as a 48h continuous i.v infusion Administration of blood pressure modules M1006B: No offset
Intervention: Drug: Iloprost + M1006B, No offset Receives: Drug: Iloprost; Device: Philips M1006B, No offset |
| Placebo + M1006B offset by -10 mmHg | Placebo comparator | Double dummy 0.9% saline as a 48h continuous i.v infusion. Administration of blood pressure modules M1006B: offset by -10 mmHg
Intervention: Drug: Placebo + M1006B offset -10mmHg Receives: Drug: Saline; Device: Phillips M1006B, offset by -10mmHg |
| Placebo + M1006B, No offset | Placebo comparator | Double dummy 0.9% saline as a 48h continuous i.v infusion Administration of blood pressure modules M1006B: No offset
Intervention: Drug: Placebo + M1006B, No offset Receives: Drug: Saline; Device: Philips M1006B, No offset |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change i plasma biomarkers reflecting endothelial activation and damage
Mean change in biomarkers indicative of endothelial activation and damage (sE-selectin, syndecan-1, soluble thrombomodulin (sTM), soluble vascular endothelial growth factor (sVEGF), nucleosomes) and sympathoadrenal overactivation (epinephrine/norepinephrine) from baseline to 48 hours post-randomization.
Measured: 48 hours
Secondary outcomes (3)
Mean change in hemostatic profile evaluated by TEG, Multiplate, Flowcytometry
Mean change in the hemostatic profile evaluated by Thrombelastography (TEG)(change in functional hemostatic blood test) and Multiplate (whole blood platelet aggregometry) and change in Flowcytometry (change in blood cell and endothelial cell derived microparticles). from baseline to 48 hours post-randomization.
Measured: 48 hours
Blood pressure target influence on primary outcomes measured by mean change in plasma biomarkers.
Blood pressure target (65 mmHg or 75 mmHg) influence on the endothelial response to the study drug (mean change in biomarkers reflecting endothelial activation and damage) and change in levels of Neuron Specific Enolasis from baseline to 48 hours post-randomization.
Measured: 48 hours
Feasibility of blood pressure target intervention.
Feasibility of blood pressure target intervention .(Target 90%)
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2016 (estimated)
- Study startFeb 2016
- Primary completion27 Aug 2016
- Study completion27 Feb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Cardiac ArrestStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pär Johansson
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Pär Johansson, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Chistian Hassager, MD, DMSc, Principal investigator, Dept. of Cardiology, 2143, Rigshospitalet, Blegdamsvej 0, DK-2100
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02685618
- Sponsor's protocol ID
- 2014092629
- Acronym
- ENDO-RCA
- Status last verified
- Mar 2021
- First submitted
- 4 Feb 2016
- Last updated
- 10 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Meyer ASP, Ostrowski SR, Kjaergaard J, Frydland M, Thomsen JH, Johansson PI, Hassager C. Low dose Iloprost effect on platelet aggregation in comatose out-of-hospital cardiac arrest patients: A predefined sub-study of the ENDO-RCA randomized -phase 2- trial. J Crit Care. 2020 Apr;56:197-202. doi: 10.1016/j.jcrc.2019.12.025. Epub 2019 Dec 30.
PubMed 31945586Meyer ASP, Johansson PI, Kjaergaard J, Frydland M, Meyer MAS, Henriksen HH, Thomsen JH, Wiberg SC, Hassager C, Ostrowski SR. "Endothelial Dysfunction in Resuscitated Cardiac Arrest (ENDO-RCA): Safety and efficacy of low-dose Iloprost, a prostacyclin analogue, in addition to standard therapy, as compared to standard therapy alone, in post-cardiac-arrest-syndrome patients.". Am Heart J. 2020 Jan;219:9-20. doi: 10.1016/j.ahj.2019.10.002. Epub 2019 Oct 21.
PubMed 31710844Meyer AS, Ostrowski SR, Kjaergaard J, Johansson PI, Hassager C. Endothelial Dysfunction in Resuscitated Cardiac Arrest (ENDO-RCA): safety and efficacy of low-dose prostacyclin administration and blood pressure target in addition to standard therapy, as compared to standard therapy alone, in post-cardiac arrest syndrome patients: study protocol for a randomized controlled trial. Trials. 2016 Aug 2;17:378. doi: 10.1186/s13063-016-1477-z.
PubMed 27484224
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Low-dose Prostacyclin Administration and Blood Pressure Target in Addition to Standard Therapy, as Compared to Standard Therapy Alone, in Post-cardiac-arrest-syndrome Patients - a Randomized, Controlled, Double-blinded Investigator-initiated Trial.
- ClinicalTrials.gov ID
- NCT02685618
- Acronym / sponsor ID
- ENDO-RCA / 2014092629
- Conditions
- Cardiac Arrest
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Pär JohanssonUniversity, hospital or other
- Study start
- Feb 2016 (actual)
- Primary completion
- 27 Aug 2016 (actual)
- Study completion
- 27 Feb 2017 (actual)
- First posted
- 19 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Objective: Safety and efficacy of low-dose prostacyclin administration and blood pressure target in addition to standard therapy, as compared to standard therapy alone, in post-cardiac-arrest-syndrome (PCAS) patients.
Detailed description
Trial Rationale: Therapeutic interventions directed towards the damaged endothelium may improve outcome for patients with PCAS. Prostacyclin/Iloprost (PGI2) is an endogenous prostanoid which is formed and released by endothelial cells with anti-platelet, vasodilatory and cytoprotective properties36 and is expected to be beneficial by protecting and deactivating the endothelium and by restoring vascular integrity in patients suffering from endothelial breakdown.
Trial Population: Participants in the trial must be adult patients (≥18 years of age) with out-of-hospital cardiac arrest (OHCA) of presumed cardiac cause admitted to the Dept. of Cardiology, 2143, Rigshospitalet, Copenhagen.
Trial Design: Randomized, placebo controlled, double-blind investigator-initiated trial in 40 OHCA patients. 48 hours of active study drug (Iloprost, 1 ng/kg/min) versus placebo (saline) infusion.
Patients in both randomization groups will be treated in accordance with state-of-the art therapy including targeted temperature management. Interventions are considered emergency procedures and study drug infusion should be commenced as soon as possible after sustained return of spontaneous circulation (ROSC), screening and randomization.
Patients will only be enrolled after informed consent, but as the treatment has to be initiated earliest possible after the out of hospital cardiac arrest diagnosis i.e., at a time-point where patients are temporarily incompetent, scientific guardians will co-sign the informed consent form before inclusion. Next-of-kin and the patients' general practitioner will co-sign as soon as possible and the patient will provide informed consent whenever possible.
During the study, blood samples will be taken at different time points. Patients will be observed and assessed continuously with regards to complications including bleeding. Patients will be actively assessed as long as the patient is in the ICU. During the extended follow up period at day 30, 90 and 180 contact will be made with the patients to follow up on safety events and vital status.
The trial is conducted in accordance with the protocol and is approved by Danish health and medicines authority, Danish ethics committee and danish data protection agency.
Investigational product: The active treatment in the trial is 1 ng/kg/min Ilomedin® administered as a 48h continuous i.v infusion. The drugs will be administered according to the product specifications.
Placebo: The placebo is 0.9% saline administered as a 48h continuous i.v infusion. The i.v volume of placebo saline to be administered is equal to the administered volume of diluted (in 0.9% saline) active drug.
Sponsor of study and financial support: This research project is investigator-initiated by the trial Sponsor Pär I. Johansson in collaboration with the principal investigator Christian Hassager.
It has not received funding from any commercial sponsors.
Patient recruitment period runs from February 2016 to August 2016. Follow-up data on 30-day, 90-day and 180-day outcome and adverse events will be collected. Initial data analyses will be done after completion of 30-day follow-up for all patients. Secondary data analyses will be done after completion of 180-day follow-up for all patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Iloprost + M1006B offset by -10 mmHg | Experimental | Drug: Iloprost, Device: Phillips M1006B, offset by -10mmHgAdministration of 1 ng/kg/min Ilomedin® as a 48h continuous i.v infusion. Administration of blood pressure modules M1006B: offset by -10 mmHg Intervention: Drug: Iloprost + M1006B offset -10mmHg |
| Iloprost + M1006B, No offset | Experimental | Drug: Iloprost, Device: Philips M1006B, No offsetAdministration of 1 ng/kg/min Ilomedin® as a 48h continuous i.v infusion Administration of blood pressure modules M1006B: No offset Intervention: Drug: Iloprost + M1006B, No offset |
| Placebo + M1006B offset by -10 mmHg | Placebo comparator | Drug: Saline, Device: Phillips M1006B, offset by -10mmHgDouble dummy 0.9% saline as a 48h continuous i.v infusion. Administration of blood pressure modules M1006B: offset by -10 mmHg Intervention: Drug: Placebo + M1006B offset -10mmHg |
| Placebo + M1006B, No offset | Placebo comparator | Drug: Saline, Device: Philips M1006B, No offsetDouble dummy 0.9% saline as a 48h continuous i.v infusion Administration of blood pressure modules M1006B: No offset Intervention: Drug: Placebo + M1006B, No offset |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥18 years
- OHCA of presumed cardiac cause
- Sustained ROSC*
- Unconsciousness (GCS <8) (patients not able to obey verbal commands) after sustained ROSC*
- Target temperature management is indicated.
Key exclusion criteria (16 listed)
- Conscious patients (obeying verbal commands)
- Females of childbearing potential (unless a negative human chorionic gonadotropin (HCG) test can rule out pregnancy within the inclusion window)
- Patients weighing more than 135kg
- In-hospital cardiac arrest (IHCA)
- OHCA of presumed non-cardiac cause, e.g. after trauma or dissection/rupture of major artery OR Cardiac arrest caused by initial hypoxia (i.e. drowning, suffocation, hanging).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IloprostAlso: Ilomedin (R), Prostacyclin analogue (PGI2) | Drug | Iloprost + M1006B offset by -10 mmHg, Iloprost + M1006B, No offset |
| SalineAlso: 0,9% NaCl | Drug | Placebo + M1006B offset by -10 mmHg, Placebo + M1006B, No offset |
| Phillips M1006B, offset by -10mmHgAdministration of blood pressure module M1006B: offset by -10 mmHg | Device | Iloprost + M1006B offset by -10 mmHg, Placebo + M1006B offset by -10 mmHg |
| Philips M1006B, No offsetAdministration of blood pressure module M1006B: No offset | Device | Iloprost + M1006B, No offset, Placebo + M1006B, No offset |
Primary outcome
Mean change i plasma biomarkers reflecting endothelial activation and damage
Time frame: 48 hours
Mean change in biomarkers indicative of endothelial activation and damage (sE-selectin, syndecan-1, soluble thrombomodulin (sTM), soluble vascular endothelial growth factor (sVEGF), nucleosomes) and sympathoadrenal overactivation (epinephrine/norepinephrine) from baseline to 48 hours post-randomization.
3 secondary outcomes
Mean change in hemostatic profile evaluated by TEG, Multiplate, Flowcytometry
Time frame: 48 hours
Blood pressure target influence on primary outcomes measured by mean change in plasma biomarkers.
Time frame: 48 hours
Feasibility of blood pressure target intervention.
Time frame: 48 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2021.
- Derived from this study: PubMed 31945586Meyer ASP, Ostrowski SR, Kjaergaard J, Frydland M, Thomsen JH, Johansson PI, Hassager C. Low dose Iloprost effect on platelet aggregation in comatose out-of-hospital cardiac arrest patients: A predefined sub-study of the ENDO-RCA randomized -phase 2- trial. J Crit Care. 2020 Apr;56:197-202. doi: 10.1016/j.jcrc.2019.12.025. Epub 2019 Dec 30.
- Derived from this study: PubMed 31710844Meyer ASP, Johansson PI, Kjaergaard J, Frydland M, Meyer MAS, Henriksen HH, Thomsen JH, Wiberg SC, Hassager C, Ostrowski SR. "Endothelial Dysfunction in Resuscitated Cardiac Arrest (ENDO-RCA): Safety and efficacy of low-dose Iloprost, a prostacyclin analogue, in addition to standard therapy, as compared to standard therapy alone, in post-cardiac-arrest-syndrome patients.". Am Heart J. 2020 Jan;219:9-20. doi: 10.1016/j.ahj.2019.10.002. Epub 2019 Oct 21.
- Derived from this study: PubMed 27484224Meyer AS, Ostrowski SR, Kjaergaard J, Johansson PI, Hassager C. Endothelial Dysfunction in Resuscitated Cardiac Arrest (ENDO-RCA): safety and efficacy of low-dose prostacyclin administration and blood pressure target in addition to standard therapy, as compared to standard therapy alone, in post-cardiac arrest syndrome patients: study protocol for a randomized controlled trial. Trials. 2016 Aug 2;17:378. doi: 10.1186/s13063-016-1477-z.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chistian Hassager, MD, DMSc principal investigator
Dept. of Cardiology, 2143, Rigshospitalet, Blegdamsvej 0, DK-2100
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Iloprost, Saline and Phillips M1006B, offset by -10mmHg in people with Cardiac Arrest, run by Pär Johansson at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean change i plasma biomarkers reflecting endothelial activation and damage (time frame: 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02685618, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2021.